Safety and Tolerability of SPD485 in Children Aged 6-12 Diagnosed With ADHD and Previously Participated in MTS Trials

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

A Phase III, Multi-center, Open-label Study of Methylphenidate Transdermal System (MTS) in Pediatric Patients Aged 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00151957
• Other study ID #: SPD485-303
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2005
• Last updated: March 27, 2017
• Start date: October 2004
• Est. completion date: June 2007

Study information

• Verified date: March 2017
• Source: Noven Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the long-term safety of MTS in the symptomatic treatment of children aged 6-12 diagnosed with ADHD

Description:

Attention-Deficit/Hyperactivity Disorder (ADHD) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. This study will evaluate the long-term safety of SPD485 in the symptomatic treatment of children aged 6-12 diagnosed with ADHD

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Subject must have participated in and completed SPD485-201 or participated in and completed a minimum of five of the seven weeks of double-blind treatment in study SPD485-302. Subjects who are participating in N17-021 may enroll in this study following completion of the End of Study/Termination visit procedures.

• Females of childbearing potential must have a negative urine pregnancy test at Baseline and must abstain from sexual activity that could result in pregnancy, or use acceptable contraceptives.

Exclusion Criteria:

• Subject was terminated from SPD485-102, SPD495-201, SPD485-302 OR N17-021 for non-compliance or experienced a serious adverse event resulting in termination from the antecedent protocols

• Female subject is pregnant or lactating

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

Drug:
• Methylphenidate Transdermal System
MTS Patch 27.5mg, 41.3mg, 55mg, and 82.5mg for 7 Weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Noven Therapeutics	Noven Pharmaceuticals, Inc.

References & Publications (1)

Findling RL, Wigal SB, Bukstein OG, Boellner SW, Abikoff HB, Turnbow JM, Civil R. Long-term tolerability of the methylphenidate transdermal system in pediatric attention-deficit/hyperactivity disorder: a multicenter, prospective, 12-month, open-label, uncontrolled, phase III extension of four clinical trials. Clin Ther. 2009 Aug;31(8):1844-55. doi: 10.1016/j.clinthera.2009.08.002. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment emergent adverse events over 12 months.		Weekly
Secondary	ADHD-RS-IV scores		Weekly
Secondary	Parent Global Assessment		Weekly
Secondary	Clinical Global Impressions Scale		Weekly
Secondary	Child's Sleep Habits Questionnaire		Weekly